GEN – 1235.00. On 21 April, the European Commission adopted a proposal for a Regulation on machinery products. This Regulation would have the effect of repealing and replacing the so-called Machinery Directive (2006/42/EC). The proposal is open for feedback from the public until 5 July 2021.

Changes

The objective of the revision is to modernise and simplify the legislation and better cover new technologies and their impact of safety, such as Artificial Intelligence and robotics. The new Regulation is also meant to provide better clarity on the scope and definitions, to improve consistency with other pieces of legislation, to update the list of high-risk machines after 15 years of innovation, and to allow digital instead of paper-based documentation.

The proposal introduces a new definition of “major change” and new procedures to ensure that machines undergoing major changes comply with essential health and safety requirement. A stricter conformity assessment procedure would apply to manufacturers that are considered “high risk”, in which case self-certification would lapse.

It should be noted that the Commission is proposing to replace the current Machinery Directive with a Regulation. Whereas Directives need to be transposed into national law and therefore permit a degree of divergence between Member States, a Regulation is directly applicable across the EU without transposition.

Timeline

The revision of the Machinery Directive started in early 2019 and has now finished with the proposal for a new Regulation. Together the with draft act, the Commission also published the annexes to the Regulation, the Impact Assessment, and the opinion of the Regulatory Scrutiny Board.

The proposal is open for feedback from the public until 22 June 2021. All feedback received will be summarised by the European Commission and presented to the European Parliament and Council with the aim of feeding into the legislative debate.

The proposal is subject to the ordinary legislative procedure. This means that both the Parliament and Council may propose amendments and must finally approve the proposal.

The procedure file in the Parliament has been opened. The file was passed to the IMCO Committee for report. The rapporteur is not yet known. The IMCO Committee next meets on 26 and 27 May.

Recommended actions

Manufacturers whose products are covered by the current Machinery Directive are recommended to study the proposal for a new Regulation and provide their feedback to the Commission before 28 June 2021. If requested by members, a joint position paper could be introduced under the Eurovent umbrella.

Related documents and links

All related documents and articles can be found in the respective sections in the right sidebar.

• GEN – 1235.01 – Machinery Regulation – Draft Act
• GEN – 1235.02 – Machinery Regulation – Annexes 1-11
• GEN – 1235.03 – Machinery Regulation – Impact Assessment summary
• GEN – 1235.04 – Machinery Regulation – Impact Assessment
• GEN – 1235.05 – Machinery Regulation – Regulatory Scrutiny Board
• Link for feedback to the Commission: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/2019-Revision-of-the-Machinery-Directive
• Commission website on Machinery Directive: https://ec.europa.eu/growth/sectors/mechanical-engineering/machinery_en